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Antiretroviral Therapy

Early ART for HIV (EARLIER Trial)

Phase 2

Waitlist Available

Research Sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability and willingness to initiate ART at enrollment

Female candidates of reproductive potential who are not pregnant at the time of enrollment and who will receive the study-provided EVG/COBI/FTC/TAF and must agree not to participate in the conception process

Must not have

Chronic or recurrent use of medications that modify host immune response, eg, oral or parenteral steroids, cancer chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 48

Awards & highlights

No Placebo-Only Group

Summary

This trial looked at whether starting antiretroviral therapy (ART) early, as soon as the infection is found, affects the amount of HIV-1 in blood and how well the body fights the HIV-1 infection.

Who is the study for?

This trial is for individuals recently diagnosed with acute HIV-1 infection who can start treatment immediately and are willing to follow the study plan for up to 72 weeks. Women of childbearing potential must use contraception, and participants should not have any health conditions that could affect their participation or be on immune-modifying drugs.

What is being tested?

The trial tests early antiretroviral therapy (ART) using FDA-approved medications like elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide among others. It aims to see how early ART affects HIV-1 levels in blood, the body's response, and the amount of virus in CD4+ T-cells after 48 weeks.

What are the potential side effects?

Potential side effects from ART may include nausea, headaches, fatigue, diarrhea, and possible allergic reactions. Long-term use might also impact liver function, bone density or cause other systemic issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am ready and willing to start antiretroviral therapy at enrollment.

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I am not pregnant and agree not to try to conceive while on the study treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly take medication that affects my immune system, like steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)

Secondary study objectives

GAG Gene

HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry

Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3: Fiebig VExperimental Treatment1 Intervention

Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).

Group II: Arm 2: Fiebig III/IVExperimental Treatment1 Intervention

Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).

Group III: Arm 1: Fiebig I/IIExperimental Treatment1 Intervention

Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).

0 / 3Eligibility criteria met